Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Technical Presentation (September 2025)
21 slides from Kyowa Kirin's technical presentation, Sep 9, 2025
Slide 1: Rocatinlimab Update: Phase 3 Study ROCKET ASCEND Topline Data
Rocatinlimab Update Phase 3 Study: ROCKET ASCEND Topline Data September 9, 2025. President and Chief Operating Officer (COO) Abdul Mullick, Ph.D. Director of the Board, Executive Vice President & Chief Medical Officer Takeyoshi Yamashita, Ph.D. Rocatinlimab is currently under clinical investigation.
Slide 2: Understanding the complexities and burden of moderate to severe AD
Understanding the complexities and burden of moderate to severe AD What are the Unmet Medical Needs for the disease? © Kyowa Kirin Co., Ltd. 1
Slide 3: Atopic Dermatitis is a chronic and heterogeneous inflammatory skin disease
Atopic Dermatitis (AD) is a chronic and heterogeneous inflammatory skin disease that imparts a significant burden on patients and caregivers Pain Itch/pruritus Sleep Mental health Daily living Productivity Social interactions Chronic Unpredictable Skin lesions Flares ⚫ Globally, up to 10% of adults
Slide 4: Despite existing therapies, a high unmet medical need remains
Despite existing therapies, a high unmet medical need remains as many patients with moderate-to-severe AD continue to experience inadequate disease control1,2,3 ⚫ Current treatment options for moderate to severe AD often fail to provide sustained relief or adequately address patient needs, highlight
Slide 5: Immune Memory Plays an Important Role in moderate-to-severe AD
Immune Memory Plays an Important Role in the pattern of moderate- to-severe AD AD follows a highly fluctuating, unpredictable, and chronic disease course, with waves of recurrence often occurring in the same area of the body1,2 Flare and immune memory Resolution Immune memory reactivation developmen
Slide 6: T-cell rebalancing therapy with Rocatinlimab
T-cell rebalancing therapy with Rocatinlimab: A novel approach for management of moderate to severe atopic dermatitis © Kyowa Kirin Co., Ltd. 5
Slide 7: T cells are Central to Inflammation that Drives AD Symptoms
T cells are Central to Inflammation that Drives AD Symptoms • T cells are a type of white blood cells that protect the body from infection1 AD Symptoms Inflammation • Hyperactive T cells play a central role in multiple aspects (Heterogeneity) of AD, including:2,3 • Inflammation T cells2,4,5 • Flares
Slide 8: Rocatinlimab targets pathogenic T-cells via the OX40 receptor
By directly targeting pathogenic T-cells via the OX40 receptor, rocatinlimab is a potentially novel approach for the management of Moderate-to-Severe AD10 OX40R–Targeted Therapies9 Rocatinlimab, potentially directly targets pathogenic Skin T-cells via OX40 receptor is a novel upstream treatment Appr
Slide 9: T-cell Rebalance: broad and sustained therapeutic effects
T-cell Rebalance – Aiming for broad and sustained therapeutic effects by addressing a root cause of inflammatory diseases Novel OX40-mediated mechanism targeting pathogenic T-cells improves T cell imbalance, root cause of inflammatory diseases, aiming for T cell rebalancing. Potential action on memo
Slide 10: Peer-Reviewed article: Rocatinlimab as a novel T-cell rebalancing therapy
Peer-Reviewed article just published: Rocatinlimab as a novel T-cell rebalancing therapy Journal: Dermatology and Therapy (September 2025) Rocatinlimab Mechanism of Action Title: Rocatinlimab: A Novel T-Cell Rebalancing Therapy Targeting the OX40 Receptor in Atopic Dermatitis Authors: Emma Gut
Slide 11: Phase 3 ROCKET Program Results to date and new study results
Phase 3 ROCKET Program Results to date and new study results © Kyowa Kirin Co., Ltd. 10
Slide 12: Rocatinlimab - Phase 3 ROCKET Program
Rocatinlimab – Phase 3 the ROCKET Program • Composed of eight global studies enrolling adult and adolescent moderate to severe AD patients • To date, over 3,300 patients have been enrolled with seven studies having completed enrollment • Studies were designed to examine long-term sustained efficacy
Slide 13: Topline Data: ROCKET IGNITE, SHUTTLE, VOYAGER
Topline Data: ROCKET IGNITE, SHUTTLE, VOYAGER https://ir.kyowakirin.com/en/news/news-3032964777820161808/main/00/link/e20250308.pdf Primary Endpoint* rocatinlimab Higher Dose (Week 24) rocatinlimab Lower Dose (Week 24) % Difference from placebo (p-value) % Difference from placebo (p-value) EASI-75 4
Slide 14: ROCKET HORIZON: EASI-75 and vIGA-AD 0/1 Responses at Week 24
ROCKET HORIZON: EASI-75 and vIGA-ADTM 0/1 Responses at Week 24 Primary analysis set (patients with any rescue use classified as non-responders) All Data as observed (patient population analyzed based on observed data regardless of rescue therapy use) EASI-75 at Week 24 vIGA-AD 0/1 at Week 24 ROCA (N
Slide 15: ROCKET HORIZON: EASI 75-89 and EASI 90-100
ROCKET HORIZON: EASI 75-89 and EASI 90-100 at Week 24 All Data as observed (patient population analyzed based on observed data regardless of rescue therapy use) ROCA (N = 543) PBO (N = 183) EASI 90-100 EASI 75-89 EASI 90-100 EASI 75-89 50 47 50 44 Percent Responders (%) Percent Responders (%) 40 39
Slide 16: ROCKET-ASCEND Trial Design: Adult Cohorts
ROCKET-ASCEND TRIAL DESIGN: ADULT COHORTS1 Study Subjects ROCKET-ASCEND Cohort (at 24 wks) (104 wks) 32-Week Interim Analysis Endpoints Adult Monotherapy Adult Randomized Treatment Withdrawal Responders† 150mg or 300mg, Q4W, Q8W or PBO Primary Endpoint: IGNITE/HORIZON* (withdrawal) monotherapy Safet
Slide 17: ROCKET ASCEND Topline: Primary Endpoint
ROCKET ASCEND Topline: Primary Endpoint 1-year Safety Profile in adult population ◼ The most frequent TEAE in adults (≥ 5 per 100 patient-years in any of the rocatinlimab groups and greater than placebo) included upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulce
Slide 18: ROCKET ASCEND Topline: Secondary Endpoints
ROCKET ASCEND Topline: Secondary Endpoints Ignite & Horizon Responders (vIGA-AD 0/1 and/or EASI-75 at W24 without use of any rescue treatment 150 mg Q4W Responders 300 mg Q4W Responders R R Rerandomized to Rerandomized to Rerandomized to Rerandomized to Rerandomized to Rerandomized to Placebo 150mg
Slide 19: Summary
Summary © Kyowa Kirin Co., Ltd. 18
Slide 20: Despite existing therapies, a high unmet medical need remains
Despite existing therapies, a high unmet medical need remains as many patients with moderate-to-severe AD continue to experience inadequate disease control1,2,3 ⚫ Current treatment options for moderate to severe AD often fail to provide sustained relief or adequately address patient needs, highlight
Slide 21: ROCKET ASCEND topline data: Executive Summary
ROCKET ASCEND topline data: Executive Summary ◼ The most frequent treatment emergent adverse events in adults in any of the rocatinlimab groups, and greater than placebo, were observed in the previous ROCKET studies. The discontinuation rate due to AEs was low across the adult rocatinlimab treated c
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